CD20-CD19 Compound CAR (cCAR) T Cells for Patients With Relapsed /Refractory B Cell Malignancies

• Sponsor: iCell Gene Therapeutics (Industry)
• Overall Status: Unknown status
• CT.gov ID: NCT04156178
• Collaborator: Peking University Shenzhen Hospital (Other), Chengdu Military General Hospital (Other), iCAR Bio Therapeutics Ltd. (Industry)
• Enrollment: 12
• Locations: 2
• Arm: 1
• Anticipated Duration (Months): 26
• Patients Per Site: 6
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

This is a phase I, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of CD20-CD19 cCAR in patients with relapsed and/or refractory B cell malignancies.

Condition or Disease	Intervention/Treatment	Phase
B Cell Lymphoma; B Cell Leukemia	Biological: CD20-CD19 cCAR T cells	Early Phase 1

Detailed Description

Clinical trials with CD19-directed CARs have achieved unprecedented remission rates as high as 90%. However, recent follow-up studies have shown a substantial portion of treated patients relapsed due to antigen escape. CD20-CD19 cCAR is a compound Chimeric Antigen Receptor (cCAR) immunotherapy with two distinct functional CAR molecules expressed on a T-cell, directed against the surface proteins CD20 and CD19. CD20-CD19 cCAR intends to target the mechanisms of single-CAR relapse, specifically antigen escape.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 12 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase I, Interventional, Single Arm, Open Label, Treatment Study to Evaluate the Safety and Tolerability of CD20-CD19 cCAR in Patients With Relapsed and/or Refractory B Cell Malignancies
• Actual Study Start Date: Aug 1, 2018
• Anticipated Primary Completion Date: Sep 30, 2020
• Anticipated Study Completion Date: Sep 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CD20-CD19 cCAR T cells CD20-CD19 cCAR T cells transduced with a lentiviral vector to express two distinct units of anti-CD20 and CD19 CARs	Biological: CD20-CD19 cCAR T cells; CD20-CD19 cCAR T cells administered to patients, will be either fresh or thawed CAR T cells by IV injection after receiving lymphodepleting chemotherapy

Outcome Measures

Primary Outcome Measures

1. Number of participants with dose limiting toxicity (DLT) as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 [28 days]

2. Type of dose-limiting toxicity (DLT) [28 days]

3. Number of participants with adverse event by severity as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 [2 years]

Secondary Outcome Measures

1. Overall Response Rate (ORR) [1 year]

   Assessment of morphologic complete remission (CR), complete remission with incomplete recovery of counts (CR1), no residual disease as analyzed by flow cytometry analysis, and molecular remission by molecular studies

2. Progression-free survival (PFS) [1 year]

3. Overall survival [1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Diagnosis based on the World Health Organization (WHO) 2008

2. Histologically demonstrate CD19 or CD20 expressing B cell lymphoma or B ALL

3. Patients have exhausted standard therapeutic options

4. Systematic usage of immunosuppressive drug or corticosteroid must have been stopped for more than 4 weeks

5. Female must be not pregnant during the study

Exclusion Criteria:

1. Patients declining to consent for treatment

2. Prior solid organ transplantation

3. Potentially curative therapy including chemotherapy or hematopoietic cell transplant

4. Prior treatment with CD20xCD3 or CD19x3 bispecific agents

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chengdu Military General Hospital	Chengdu		China
2	Peking University Shenzhen Hospital	Shanghai		China

Sponsors and Collaborators

• iCell Gene Therapeutics
• Peking University Shenzhen Hospital
• Chengdu Military General Hospital
• iCAR Bio Therapeutics Ltd.

Investigators

• Principal Investigator: Hongyu Zhang, MD, PhD, Peking University Shenzhen Hospital
• Principal Investigator: Fang Liu, MD, PhD, Chengdu Military General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: iCell Gene Therapeutics
• ClinicalTrials.gov Identifier: NCT04156178
• Other Study ID Numbers: ICG133-001
• First Posted: Nov 7, 2019
• Last Update Posted: Nov 12, 2019
• Last Verified: Jan 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by iCell Gene Therapeutics: CD20; CD19; cCAR; Leukemia; Lymphoma
• Additional relevant MeSH terms: Leukemia, B-Cell; Leukemia, Lymphocytic, Chronic, B-Cell

Study Results

No Results Posted as of Nov 12, 2019